Roche-AbbVie cancer drug gets accelerated FDA approval

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FILE PHOTO: The logo of Swiss pharmaceutical company Roche is seen outside the Shanghai Roche Pharmaceutical Co. Ltd. headquarters in Shanghai May 22, 2014. Swiss drugmaker Roche Holding AG said it had been visited by a unit of China's anti-trust regulator. It was not immediately clear what was behind the visit. REUTERS/Aly Song

(Reuters) - Roche Holding AG said on Wednesday its cancer drug, Venclexta, received accelerated approval from the U.S. Food and Drug Administration as part of a combination treatment for newly diagnosed patients with a form of leukemia.

The drug, developed in partnership with AbbVie Inc, was approved for patients with acute myeloid leukemia (AML) aged 75 or older, or those ineligible for intensive induction chemotherapy.

“Many people with acute myeloid leukemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients,” said Sandra Horning, chief medical officer at Genentech, a unit of Roche.

Venclexta has been previously approved for forms of chronic lymphocytic leukemia, and a late-stage study recently showed that it helped reduce the risk of disease worsening when used with Roche’s cancer drug Gazyva.

AML, the most common type of the aggressive blood cancer in adults, has the lowest survival rate for all types of leukemia, the company said. The American Cancer Society estimates about 19,520 new cases of the cancer in the United States this year.

(This story corrects fourth paragraph to show study was late-stage, not mid-stage)